Case Name: Bayer Intellectual Prop. GmbH v. Aurobindo Pharma Ltd., No. 15-902, 2018 U.S. Dist. LEXIS 116931 (D. Del. July 13, 2018) (Stengel, C.J.)....more
11/5/2018
/ Abbreviated New Drug Application (ANDA) ,
Bayer ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art
Case Name: Amgen Inc. v. Amneal Pharms. LLC, Civ. No. 16-0853 (MSG), 2018 U.S. Dist. LEXIS 125631 (D. Del. July 27, 2018) (Goldberg, J.)....more
11/2/2018
/ Abbreviated New Drug Application (ANDA) ,
Amgen ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Pernix Ir. Pain DAC v. Alvogen Malta Operations, Ltd., No. 16-139, 2018 U.S. Dist. LEXIS 144226 (D. Del. Aug. 24, 2018) (Bryson, J.)....more
11/1/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Galderma Labs., L.P. v. Amneal Pharmaceuticals LLC, No. 16-207-LPS, 2018 U.S. Dist. LEXIS 151037 (D. Del. Aug. 27, 2018) (Stark, C.J.)....more
10/31/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art
Case Name: Endo Pharms. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374, 2018 U.S. App. LEXIS 19265 (Fed. Cir. July 13, 2018) (Circuit Judges Moore, Linn, and Chen presiding; Opinion by Chen, J.) (Appeal from D. Del., Robinson,...more
10/29/2018
/ Abbreviated New Drug Application (ANDA) ,
Endo Pharmaceuticals ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art
Case Name: Supernus Pharms., Inc. v. TWi Pharms., Inc., Fed. Cir. No. 2017-2513, 2018 U.S. App. LEXIS 25271 (Fed. Cir. Sept. 6, 2018)....more
10/26/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Acorda Therapeutics, Inc. v. Roxane Labs., Inc., Fed. Cir. Nos. 2017-2078, -2134, 2018 U.S. App. LEXIS 25536 (Fed. Cir. Sept. 10, 2018) (Circuit Judges Newman, Dyk, and Taranto presiding; Opinion by Taranto, J.;...more
10/24/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Roxane Laboratories
Case Name: Pernix Ir. Pain DAC v. Alvogen Malta Operations, Ltd., Civ. No. 16-139-WCB, 2018 U.S. Dist. LEXIS 81419 (D. Del. May 15, 2018) (Bryson, C.J.)....more
8/1/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Summary Judgment
Case Name: Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. Apr. 13, 2018) (Circuit Judges Prost, Lourie, and Hughes presiding; Opinion by Lourie, J.; Dissent by Prost, C.J.) (Appeal from D. Del.,...more
7/26/2018
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Sumitomo Dainippon Pharma Co. v. Emcure Pharms. Ltd., Fed. Cir. Nos. 2017-1798, 2017-1799, 2017-1800 (Fed. Cir. Apr. 16, 2018) (Circuit Judges Moore, Mayer, and Stoll presiding; Opinion by Stoll, J.) (Appeals from...more
7/25/2018
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Endo Pharms. Inc. v. Teva Pharms. USA, Inc., Fed. Cir. Nos. 2015-2021, -2022, -2023, -2024, -2025, -2026, -2028, -2031, -2033, -2034, -2035, -2041, -2042, -2046, -2047, -2049, -2059, -2060, 2016-1025, -1060, -1117,...more
7/24/2018
/ Abbreviated New Drug Application (ANDA) ,
Endo Pharmaceuticals ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art ,
Teva Pharmaceuticals
Case Name: Hospira, Inc. v. Amneal Pharms. LLC, No. 15-cv-697, 2018 U.S. Dist. LEXIS 9307 (D. Del. Jan. 22, 2018) (Andrews, J.)....more
5/10/2018
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
Generic Drugs ,
Hatch-Waxman ,
Hospira ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Helsinn Healthcare S.A. v. Dr. Reddy’s Labs., Ltd., Nos. 14-4274 (SRC), -6341 (SRC) (Consol.) (D.N.J. Jan. 30, 2018) (Chesler, J.)....more
5/9/2018
/ Abbreviated New Drug Application (ANDA) ,
Dr. Reddy’s Labs. ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: iCeutica Pty v. Lupin Ltd., Civ. No. MJG-17-0394, 2018 U.S. Dist. LEXIS 16526 (D. Md. Feb. 1, 2018) (Garbis, J.)....more
5/8/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Celgene Corp. v. Hetero Labs Ltd., 17-3387 (ES) (MAH), 2018 U.S. Dist. LEXIS 34025 (D.N.J. Mar. 2, 2018) (Salas, J.)....more
5/2/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Venue
Case Name: Impax Labs., Inc. v. Actavis Labs. FL, Inc., Civ. No. 15-6934, 2018 U.S. Dist. LEXIS 38623 (D.N.J. Mar. 8, 2018) (Chesler, J.)....more
5/1/2018
/ Abbreviated New Drug Application (ANDA) ,
Actavis Inc. ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Shire LLC v. Abhai, LLC, Nos. 15-13909-WGY (D. Mass. Mar. 22, 2018) (Young, J.).
Drug Product and Patent(s)-in-Suit: Adderall® XR (dextroamphetamine sulfate / dextroamphetamine saccharate / amphetamine aspartate...more
4/30/2018
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Indivior Inc. v. Mylan Techs. Inc., 15-cv-1016-RGA, 15-cv-0477-RGA, 2018 U.S. Dist. LEXIS 47151 (D. Del. Mar. 22, 2018) (Andrews, J.)....more
4/27/2018
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: The Medicines Co. v. Hospira, Inc., 2014-1469, 2014-1504 (Fed. Cir. Feb. 6, 2018) (Circuit Judges Dyk, Wallach, and Hughes presiding; Opinion by Hughes, J.) (Appeal from D. Del., Andrews, J.)....more
4/24/2018
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Hospira ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC, 881 F.3d 1376 (Fed. Cir. 2018) (Circuit Judges Taranto, Clevenger, and Stoll presiding; Opinion by Stoll, J.) (Appeal from D. Del., Robinson, J.)....more
4/23/2018
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Merck ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Otsuka Pharm. Co. v. Mylan Inc., Civ. No. 14-4508 (JBS-KMW), 2017 U.S. Dist. LEXIS 184160 (D.N.J. Nov. 7, 2017) (Simandle, J.)....more
2/12/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
Otsuka Pharmaceutical ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Galderma Labs., L.P. v. Teva Pharms USA, Inc., Civ. No. 3:17-cv-01076-M (N.D. Tex. Nov. 11, 2017) (Lynn, J.).
Drug Product and Patent(s)-in-Suit: Soolantra® (ivermectin); U.S. Patents Nos. 8,815,816 (“the ’816...more
2/9/2018
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Teva Pharmaceuticals
Case Name: Brigham & Women’s Hospital, Inc. v. Perrigo Co., Civ. No. 13-11640-RWZ, 2017 U.S. Dist. LEXIS 190604 (D. Mass. Nov. 17, 2017) (Zobel, S.J.)....more
2/8/2018
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Novartis Pharms. Corp. v. West-Ward Pharms. Int’l Ltd., 15-cv-474-RGA, 2017 U.S. Dist. Lexis 205600 (D. Del. Dec. 14, 2017) (Andrews, J.)....more
2/6/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Novartis ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Amgen Inc. v. Alkem Labs. Ltd., Civ. No. 17-cv-815-GMS, -817-GMS, 2017 U.S. Dist. LEXIS 208124 (D. Del. Dec. 19, 2017) (Sleet, J.).
Drug Product and Patent(s)-in-Suit: Sensipar® (cinacalcet HCl); U.S. Patent...more
2/5/2018
/ Abbreviated New Drug Application (ANDA) ,
Amgen ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs